Kornimate/medical-research-clean huggingface dataset:
effect of non-estrogenic pollen extract pcc-100 on hot flushes

Conditions: Breast Cancer; Hot Flashes; Postmenopausal Symptoms

Summary: many postmenopausal women have vasomotor symptoms during adjuvant hormonal treatment for breast cancer. pcc-100 is a pollen extract used for alleviation of postmenopausal symptoms. in a randomised, double blinded study pollen extract pcc-100 will be used to treat vasomotor complaints in postmenopausal women under adjuvant hormonal treatment and also in menopausal women without a history of breast cancer.


Eligibility criteria:
inclusion criteria: * postmenopausal women, between 50 and 65 years old (extremes included) at the time of signing the informed consent form; * spontaneous amenorrhea for at least 6 consecutive months in combination with a hormonal diagnosis of being postmenopausal (fsh \> 40 mu/ml and e2 \< 20 pg/ml. in subjects using tamoxifen, only e2 needs to be determined) or spontaneous amenorrhea for at least 12 consecutive months or having had a bilateral oophorectomy at least 6 weeks prior to screening (with or without hysterectomy); * a history of breast cancer, whatever the received treatment, and currently taking aromatase inhibitors or tamoxifen since at least 4 weeks. this criterion is not applicable to the 100 subjects entering the study without a history of breast cancer; * a minimum of 49 moderate to severe hot flushes or night sweats during 7 consecutive 24-h periods; * a body mass index \[bmi\] between 18.0 and 35.0 kg/m2, inclusive; * proven normal glycaemia and normal thyroid function as evidenced in a recent serum analysis (in the last year) performed by the general practitioner or gynaecologist; * the subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions. exclusion criteria: * recently, an abnormal cervical pap smear that requires surgery within 6 months; * acute or chronic thromboembolic disease, liver disease and/or renal impairment; * uncontrolled diabetes mellitus; * uncontrolled hypertension; * uncontrolled thyroid disorders; * the subject has a history of a major depression or post-traumatic stress disorder \[ptsd\] within 2 years of screening. women taking antidepressants can be included after a wash out period of 6 weeks; * use of (non-)hormonal treatments to reduce hot flushes, unless a wash-out period is respected; * a history or presence of allergy or intolerance to the investigational product or any component of the investigational product or drugs in this class. or history of drug or other allergy that, in the opinion of the investigator contraindicates subject participation; * a history of alcohol or substance abuse or dependence in the 12 months before screening as determined by the investigator; * judged by the investigator to be unsuitable for any reason.
functional dyspepsia (fd) - clinical response to montelukast in children

Conditions: Eosinophilia; Dyspepsia

Summary: duodenal eosinophilia has been associated with dyspepsia in adults and the investigators have previously described the finding of duodenal mucosal eosinophilia in 71-79% of children undergoing diagnostic endoscopy. previous studies in children have shown positive response to montelukast with approximately 50% finding complete relief and 20-30 percent showing no response. there are a number of factors that have the potential to contribute to the observed variability in response to montelukast. these include variability in: 1. systemic drug exposure (drug absorption, biotransformation and/or elimination) 2. regulation of leukotriene biosynthesis 3. cysteinyl leukotriene receptors and downstream mediators 4. patient disease phenotype (e.g. functional gastrointestinal disorder (fgid) disease classification, psychologic profile) in this study, the investigators propose to utilize biopsy specimens stratified by drug response to identify candidate gene expression modules that will be validated in a prospective study design. the overall goal of this program is to develop a signature of montelukast response that can be applied not only to eosinophilic gastroenteritis, but more generally to other diseases, such as asthma, where the drug is widely used with variable success.


Eligibility criteria:
inclusion criteria: * ages 8 - 17 years, inclusive * abdominal pain of at least 8 weeks duration and fulfilling symptom- based criteria for functional dyspepsia * scheduled for endoscopy following failure to respond to acid-reduction therapy * evidence of written parental permission (consent) and subject assent exclusion criteria: * previous treatment with montelukast * treatment with corticosteroids or oral cromolyn sodium in the four weeks prior to enrollment * prior history or clinical signs/symptoms of chronic disease requiring regular medical care (e.g., diabetes mellitus, juvenile idiopathic arthritis, cystic fibrosis or cancer) * exposure within the past two weeks to drugs or natural products that induce cyp2c8/9 or cyp3a4, including amprenavir, carbamazepine, lopinavir/ritonavir, nafcillin, nevirapine, oxcarbazepine, phenobarbital, phenytoin, rifampin, st. john's wort, or that inhibit cyp2c8/9 or cyp3a4, such as ciprofloxacin, clarithromycin, erythromycin, fluconazole, fluvoxamine, grapefruit juice, paroxetine, sertraline, sulfamethoxazole, trimethoprim * a body mass index of 30 or greater * non-english speaking * those patients who will turn 18 during the duration of the study

Keywords: duodenal eosinophilia functional dyspepsia mucosal eosinophilia
[124i]fiau pet-ct scanning in patients with pain in a prosthetic knee or hip joint

Conditions: Prosthetic Joint Infections

Summary: this protocol will evaluate the sensitivity and specificity of \[124i\]fiau as a diagnostic imaging agent for the detection of prosthetic joint infections in patients.


Eligibility criteria:
inclusion criteria: 1. males or females age \>18 years 2. ability to provide informed consent 3. a plain anterior-posterior (ap) and frog leg lateral x-ray of the hip or knee within 6 weeks of enrollment 4. need for operative intervention in the opinion of the surgeon to correct the pain in the prosthetic joint 5. prosthetic joint implant that has been in site for more than 3 months prior to enrolment 6. having adequate general health to be expected to tolerate surgery adn to survive for 6 months from the time of informed consent 7. women must be either postmenopausal or surgically sterile 8. ability to return for all study assessments 9. clinically euthyroid, or on stable thyroid replacement therapy exclusion criteria: 1. subjects who are unable to comply with study requirements 2. indication, in the opinion of the principal investigator, for urgent surgery that would preclude the time needed for pet-ct scanning 3. history of an inherited mitochondrial disorder (e.g., leber's hereditary neuropathy; neuropathy; ataxia, retinitis pigmentosa and ptosis \[narp\]; myoneurogenic gastrointestinal encephalopathy \[mngie\]; myocolonic epilepsy with ragged red fibers \[merff\]; and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome \[melas\]) 4. alanine aminotransferase (alt) \>5x the upper limit of normal (uln) or aspartate aminotransferase (ast) \>5x uln 5. creatinine clearance \<30 ml/min 6. body mass that exceeds the rating of the ct table 7. hypersensitivity to iodine 8. any condition that would put the subject at reasonable risk in the opinion of the investigator

Keywords: phase ii fiau fialuridine prosthetic joint infection pet-ct
docetaxel in treating patients with stage ii or stage iii prostate cancer

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of docetaxel in treating patients who have stage ii or stage iii prostate cancer.

objectives: i. determine the pathologic complete response rate to docetaxel in patients with high risk stage ii or iii prostate cancer. ii. determine the toxicity of this treatment in these patients. iii. correlate clinical measures of response (e.g., symptoms, physical exam, serum psa, and endorectal mri) with pathologic response to this treatment in these patients. outline: patients receive docetaxel iv over 30 minutes weekly for 4 weeks. treatment continues for 2-6 courses in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 19-45 patients will be accrued for this study over 18 months.

Eligibility criteria:
eligibility criteria: * histologically confirmed adenocarcinoma of the prostate * potential candidate for radical prostatectomy * any of the following: * clinical stage t3 patients * serum psa at least 20 ng/ml * gleason score 8-10 * clinical t2 disease and either of the following: * mri evidence of seminal vesicle involvement * gleason 4+3 cancer with either 5 or 6 biopsies positive * calgb 0-1 * wbc greater than 3,000/mm3 * hematocrit greater than 30% * platelet count greater than 100,000/mm3 * sgot, total bilirubin within normal limits * signed informed consent exclusion criteria: * no prior hormones, radiation or chemotherapy for prostate cancer * evidence of serious active infection

Keywords: adenocarcinoma of the prostate stage ii prostate cancer stage iii prostate cancer
assessing health-related quality of life and willingness to pay for weight management in asia-pacific by gender

Conditions: Overweight; Obesity

Summary: the purpose of this survey is to collect information for scientific research and to identify the impact of overweight and obesity on health-related quality of life.


Eligibility criteria:
inclusion criteria: 1. informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. male or female, age above or equal to 18 years at the time of signing informed consent. 3. not currently pregnant 4. does not participate in intense fitness or body building program 5. weight loss not through illness or injury 6. lives in south korea, australia, or india 7. bmi above or equal to 18 and associated weight class (normal weight or above) will be determined by a programmed calculation based on participant-reported height and weight. exclusion criteria: 1. previous participation in this study. participation is defined as having given informed consent in this study 2. mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation 3. does not meet inclusion criteria.
intra-abdominal pressure (iap) during pfa treatment of a-fib/ a-flutter

Conditions: Intra-Abdominal Hypertension

Summary: the purpose of this study is to investigate the intra-abdominal pressure utilizing the accuryn monitoring system during pulsed field ablation procedures in the electrophysiology lab compared to the type of anesthetic utilized.

intra-abdominal pressure (iap) may play a role in patient outcomes during ablation procedures, as increased iap could indicate potential adverse events. such adverse events include aspiration of stomach contents, which can lead to respiratory issues post procedure and unplanned admission to the hospital post procedure. potrero medical has manufactured a foley based monitoring system that has been fda cleared for the indication of measuring intra-abdominal pressure. the accuryn monitor allows for continuous, real-time measurement of iap and urine output, providing data that may enhance procedural safety and provide insights into any physiological responses unique to pulsed field ablation (pfa). this study aims to compare pfa in terms of safety, efficacy, and iap changes based on type of anesthesia received.

Eligibility criteria:
inclusion criteria: * adult patients receiving pulse field ablation procedures for standard of care treatment of atrial fibrillation and/or atrial flutter. * eligible for foley catheter placement with no contraindications to intra-abdominal pressure (iap) monitoring. exclusion criteria: * patients under the age of 18 will be excluded. * history of intra-abdominal surgery within the past 6 months. * known contraindications to bladder catheterization or catheter ablation; history of prostate issues / benign prostatic hyperplasia (bph) or frequent urinary tract infections * pregnant or breastfeeding individuals * history of chronic obstructive pulmonary disease (copd) with home oxygen use

Keywords: atrial fibrillation atrial flutter pulsed field ablation
effects of tdcs on quadriceps strength after stroke

Conditions: Stroke

Summary: previous studies show that one session of tdcs allow to improve muscle strength in hemiparetic patients in anodal condition. we test a new electrods configuration : a anodale stimulation opposite to the cortical representation area of the injured hemisphere and a simultaneous stimulation opposite to the homonyme the cortical representation area of the healthy hemisphere. this approach seems to be the best relevant electrods configuration in order to restore the inter-hemispheric balance. we hypothesis that one session of tdcs with this electrods configuration allow to improve paretic quadriceps strength in hemiparetic patients after stroke.


Eligibility criteria:
inclusion criteria: * written consent * hemiparetic patient after stroke in chronic phase (\> 6 months) * capacity to walk with or without technical assistance * following rehabilitation program for lower limbs exclusion criteria: * patient with bilateral brain lesion, cerebellar syndrom, and apraxia and/or aphasia * previous orthopedic surgery in paretic lower limb (\<6 moths) * usual tdcs contraindications * pregnant woman

Keywords: tdcs stroke force spasticity gait emg isokinetic
effects of virtual reality based training on posture stability in parkinson's disease

Conditions: Parkinson's Disease

Summary: the present study is to examine the effects of a virtual reality based balance training using the kinect sensor on postural stability and functional balance in individuals with parkinson's disease.


Eligibility criteria:
inclusion criteria: * hoehn and yahr stages i through iii * a score of more than or equal to 24 on the mini-mental state examination * stable medication usage * freedom from any other problems that might affect training exclusion criteria: * unstable medical conditions * histories of other diseases known to interfere with participation in the study

Keywords: virtual reality postural stability balance training parkinson's disease
topical oxybutynin for treatment of hyperidrosis: local or systemic effect?

Conditions: Hyperhidrosis; Oxybutynin; Sweat Gland Diseases; Skin Diseases; Autonomic Agents; Cholinergic Antagonists; Parasympatholytics

Summary: the today trial is a study to evaluate the efficacy and safety of topical oxybutynin deodorant for use in patients with axillary hyperhidrosis.

background: anticholinergics, both orally and topically, have been shown to enhance quality of life and reduce sweat in patients with hyperhidrosis, potentially obviating the need for surgical interventions. however, it remains unclear whether topical application specifically exerts local or systemic effects in patients with axillary hyperhidrosis. this study's primary aim is to assess topical oxybutynin's impact on axillary hyperhidrosis. study design: twenty patients (initially planned sample size) diagnosed with axillary hyperhidrosis will be randomized into three groups. group a will receive 2.5 mg of oral oxybutynin once daily at night for the first seven days, 2.5 mg twice daily from the 8th to the 21st day, and 5 mg twice daily from the 22nd to the 35th day. group b will be administered a topical placebo as an oxybutynin spray, applying two sprays to each axilla twice daily for 35 days. group c will receive a 10% oxybutynin topical spray, also used with two sprays to each axilla twice daily over 35 days (investigational product). the primary efficacy outcome will be the evaluation of the effectiveness of topical oxybutynin spray in treating hyperhidrosis, assessed by the number of patients showing an improvement in the severity of their condition by day 35, as measured by the hyperhidrosis disease severity scale (hdss). safety will be assessed by adverse and severe adverse events during the treatment summary: the today trial will generate high-quality evidence on the effects of topical oxybutynin, assessing whether its impact is local or systemic in patients with axillary hyperhidrosis.

Eligibility criteria:
inclusion criteria: * patients aged ≥18 years and ≤ 45 years * not treated patient with another drug or treatment methodology for the disease for at least 30 days exclusion criteria: * patients who are hypersensitive to oxybutynin hydrochloride. * not treated patient with another drug or treatment methodology for the disease for at least 30 days * patients who have menopausal symptoms * patients who show signs of skin lesions in the armpit * pregnancy. women with the potential to bear children should be under contraceptive strategies and take a negative pregnancy test to be enrolled * patients with covid in the contagious phase (pcr+)

Keywords: hyperhidrosis oxybutynin anticholinergic axillary hyperhidrosis
phase i/ii study of escalating doses of idarubicin orally given with oral cyclophosphamide, etoposide, prednisolone and intravenous rituximab in elderly patient with disseminated high grade non hodgkin lymphoma

Conditions: High Grade Lymphomas CD20 Positive

Summary: r-chop with doxorubicin is the standard first line treatment of high grade non-hodgkin's lymphoma. in order to avoid central venous system insertion and reduce hospitalization time in elderly patients, we developed an oral chemotherapy treatment: " orociep"trial. nineteen patients were enrolled and 127 chemotherapy cycles were available for toxicities. the estimated two-years overall survival was 74%. the main haematological toxicity was neutropenia. this study is still ongoing to confirm recommended dose of oral anthracycline.


Eligibility criteria:
inclusion criteria: * cd20-positive diffuse large b-cell lymphoma.who classification (55) * written informed consent * age \> 65 and \< 80 years * performance status (ecog) \<3 * measurable disease * serology hiv negative, hepatites b, hepatites c negative exclusion criteria: * serology hiv positive, hepatite b positive, hepatite c positive * cardiac failure.
pars plana vitrectomy with 25-gauge 20000 cpm, bevel-tip cutter

Conditions: Vitrectomy; Retinal Detachment; Vitreous Hemorrhage; Macular Holes; Epiretinal Membrane; Dislocated Intraocular Lens Into Vitreous; Retained Lens Fragments

Summary: report efficiency and clinical outcomes using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe among eyes with various vitreo-retinal diseases

we will evaluate the efficiency and clinical outcomes of pars plana vitrectomy using a 25-gauge, bevel-tip, 10 and 20000 cpm vitrectomy probe among eyes with 8 main surgical indications. main outcome measures included efficiency measures, postoperative pain and complications.

Eligibility criteria:
inclusion criteria: * all eyes undergoing pars plana vitrectomy with surgically amenable vitreoretinal disease. exclusion criteria: * history of prior ppv, glaucoma, scleral thinning, and active or recent history of (\<3 months) ocular or extra-ocular infection

Keywords: small gauge vitrectomy probe 20000 cut per minute microincisional vitrectomy system
compound edaravone injection for acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: 1. to investigate the efficacy and safety of multi-doses compound edaravone injection versus edaravone injection for acute ischemic stroke patients; 2. to provide evidence for the design of compound edaravone injection phase iii trial.


Eligibility criteria:
inclusion criteria: * hospitalized patients, diagnosed of ischemic stroke; * onset of stroke is less than or equal to 48 hours; * there are clear signs of neurological deficit: 4≤nihss score≤24, and also, the sum of nihss score for the upper limb and the lower limb is greater than or equal to 2; * patients signed written inform consent. exclusion criteria: * cranial ct scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage; * iatrogenic stroke; * severe disturbance of consciousness: nihss category 1a for consciousness is greater than 1； * the mrs score prior to this onset is greater than 1; * transient ischemic attack (tia); * sbp after blood pressure control is still greater than to equal to 220 mmhg, or dbp after blood pressure control is still greater than or equal to 120 mmhg; * patients with severe mental disorders and dementia; * alt or ast is greater than 2.0×uln or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis; * creatinine clearance is less than 30 ml/min or previously known severe renal diseases; * therapeutic neuroprotective agents have been applied after onset, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, urinary kallidinogenase; * arterial or venous thrombolytic therapy has been applied after onset; * with malignant tumors or receiving concurrent antitumor treatment; * with severe systemic disease, life expectancy is less than 90 days; * pregnant or lactating women; * participate in other clinical studies within 30 days before randomization; * the investigators consider the patients are not suitable for this trial.
study of romosozumab (amg 785) in tibial diaphyseal fractures status post intramedullary nailing

Conditions: Fracture Healing

Summary: the primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).


Eligibility criteria:
inclusion criteria: * skeletally mature adults, age 18 to 85 years with radiographically closed growth plates * fresh unilateral closed or gustilo type i or type ii open tibial fracture * definitive fracture fixation with reamed (closed and open fractures) or unreamed (open fractures only) intramedullary nailing exclusion criteria: * major polytrauma or significant axial trauma * associated lower extremity fracture that will delay subject's ability to bear weight beyond the normal time expected for a tibial shaft fracture * use of bone grafts at the time of fracture fixation * pathological fracture or metabolic or bone disease * history of symptomatic spinal stenosis or facial nerve paralysis * malignancy within the last 5 years * evidence of the following (currently or within the past 5 years): elevated transaminases, significantly impaired renal function, current hyper- or hypocalcaemia * use of agents affecting bone metabolism * subject refuses to use appropriate methods of contraception

Keywords: fracture healing tibial diaphyseal fracture